OSTEOVATION CMF BONE VOID FILLER

K051784 · Skeletal Kinetics, LLC · GXP · Jul 20, 2005 · Neurology

Device Facts

• Record ID: K051784
• Device Name: OSTEOVATION CMF BONE VOID FILLER
• Applicant: Skeletal Kinetics, LLC
• Product Code: GXP · Neurology
• Decision Date: Jul 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.

Device Story

OsteoVation CMF is a calcium phosphate bone void filler; supplied as a single-use product. Applied by injection or digital impaction into targeted bone voids or defects. Used by surgeons in clinical settings for craniofacial reconstruction. Acts as a scaffold for bone repair/augmentation. Provides structural filling of defects; restores bony contours. Benefits patient by facilitating repair of neurosurgical and craniofacial bone voids.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Calcium phosphate bone void filler; single-use. Material composition modified from predicate. No specific ASTM standards or software/connectivity features described.

Indications for Use

Indicated for repair or filling of neurosurgical burr holes, craniofacial defects, and craniotomy cuts (surface area ≤ 25cm²) and restoration/augmentation of craniofacial skeletal contours (fronto-orbital, malar, mental areas).

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• Callos Bone Void Filler (K051123)
• Callos CMF Bone Void Filler (K042072)

Submission Summary (Full Text)

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K051784

JUL 20 2005

# 510(k) Summary

## Skeletal Kinetics, LLC OsteoVation™ CMF Bone Void Filler

| General Information | |
|--------------------------------------------------------|----------------------------------------------------------------------------------|
| Submitters Name/Address: | Skeletal Kinetics<br>10201 Bubb Road<br>Cupertino, CA 95014 |
| Establishment Registration Number: | 3003890476 |
| Contact Person: | Duran Yetkinler<br>Vice President, Product Development<br>and Regulatory Affairs |
| Phone Number: | [phone] |
| Date Prepared: | June 30, 2005 |
| Device Description | |
| Trade Name: | OsteoVation CMF Bone Void Filler |
| Generic/Common Name: | Hydroxyapatite Cement |
| Classification Name: | 84 GXP |
| Predicate Devices | |
| Callos Bone Void Filler<br>Callos CMF Bone Void Filler | K051123; cleared on June 3, 2005<br>K042072; cleared on Sept. 16, 2004 |

### Product Description

OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.

#### Intended Use

OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.

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## Substantial Equivalence

This Special 510(k) proposes a modification in materials for Osteo Vation, which was previously cleared under K042072 on June 3, 2005. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Osteo Vation remain the same as in the predicate cleared 510(k)s.

### Summary of Safety and Effectiveness

OsteoVation, as described in this submission, is substantially equivalent to the predicate, unmodified Callos CMF. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of OsteoVation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, rendered in a simple, abstract design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 2005

Duran Yetkinler, M.D. Ph.D. Vice President, Product Development and Regulatory Affairs 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Skeletal Kinetics, LLC 10201 Bubb Road Cupertino, California 95014

Re: K051784

Trade/Device Name: OsteoVation™ CMF Bone Void Filler Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: FWP, GXP Dated: June 30, 2005 Received: July 1, 2005

Dear Dr. Yetkinler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Duran Yetkinler, M.D. Ph.D

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. ・。

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Erik. Th

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known)

OsteoVation™ CMF Bone Void Filler Device Name:

Indications for use:

OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) AND/OR

X

Over-the-Counter Use (21 CFR 801 Subpart C)

Signature

on of General, Restorative rolos

J2C(c) Number K051784